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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Details as Recorded in OASIS by FDA

for Refusal AEK-0283388-3/1/6


Manufacturer FEI3009021883
Manufacturer NameInverpal Eu  
Manufacturer Address line 1Cra 74 No 75-165  
Manufacturer Address line 2  
Manufacturer's CityBarranquilla  
Manufacturer Province/State  
Manufacturer Country/AreaColombia  
Product Code53AY02  
FDA Product DescriptionLOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS)  
Refusal Date30-Aug-2012  
FDA DistrictFLA-DO  
Entry/doc/line/sfx AEK-0283388-3/1/6
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
COSM COLOR   601(e), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).  
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